India Proposes Major Drug Law Overhaul to Tackle Opioid Crisis
In a significant regulatory move, India's apex drug authority is planning comprehensive amendments to the Drugs and Cosmetics Act to address the growing menace of pharmaceutical opioid diversion. The proposed changes aim to substantially increase penalties, bringing them in line with the stringent Narcotic Drugs and Psychotropic Substances (NDPS) Act.
Enhanced Penalties and Regulatory Framework
The Drugs Controller General of India (DCGI) has put forward a proposal that would increase imprisonment duration from the current two years to a minimum of seven years. Financial penalties would see a dramatic rise from ₹20,000 to at least ₹5 lakh. Furthermore, these offences would become cognizable and non-bailable, marking a substantial shift from the current bailable provisions.
According to government documents reviewed by Mint, the existing legal framework under the Drugs and Cosmetics Act has proven inadequate in curbing the diversion of habit-forming pharmaceutical opioids. The proposed amendments seek to create a more robust deterrent mechanism against illegal activities in India's $50 billion pharmaceuticals market.
Rising Opioid Diversion and Seizures
The urgency for stricter regulations is underscored by alarming statistics from the Narcotics Control Bureau (NCB) and Ministry of Home Affairs. Seizures of pharmaceutical tablets used as psychotropic substances have witnessed a dramatic increase:
- 18.4 million units seized in FY21
- 46.9 million units seized by FY25
This represents more than a 150% increase in just four years, highlighting the scale of the diversion problem. A 2019 government report by the Ministry of Social Justice estimated approximately 2.5 million dependent users of pharmaceutical opioids in the country.
Targeted Drug Categories and Monitoring Systems
The regulatory focus centers on highly-regulated drug categories that account for about 30% of high-value prescription medications, according to industry estimates from the Indian Pharmaceutical Alliance (IPA). These include:
- Schedule H drugs: Prescription-only medications marked 'Rx'
- Schedule H1 drugs: Stricter category requiring red-boxed warnings and special sales registers
- Schedule X drugs: Potent narcotics with high abuse potential marked 'XRx'
Specific formulations under scrutiny include:
- Codeine-based syrups
- Alprazolam (for anxiety treatment)
- Tramadol (opioid analgesic for severe pain)
- Zolpidem (for insomnia)
- Diazepam (for muscle spasms and alcohol withdrawal)
The proposed regulatory framework includes creating a separate schedule for such drug formulations and implementing a mandatory real-time tracking system for purchase orders. This digital trail would require drug manufacturers to furnish formal purchase orders and immediately notify authorities upon dispatch of medicine batches, including emailing details to drug inspectors and superintendents of police in relevant jurisdictions.
Industry Concerns and Implementation Challenges
While the government pushes for stricter controls, industry stakeholders and public health experts have raised significant concerns about the proposed measures. The pharmaceutical industry, represented by organizations like the Indian Drugs Manufacturing Association (IDMA), argues that the proposal creates unnecessary duplication since these substances are already governed by the comprehensive NDPS Act.
Devesh Malladi, chairman of the NDPS Committee at IDMA, stated that introducing overlapping compliance requirements risks regulatory confusion, multiple inspections, and duplicative reporting without necessarily improving enforcement outcomes. He emphasized that the NDPS Act already mandates stringent controls with severe penal provisions.
Public health experts have also cautioned against setting the regulatory bar too high. Dr. Atul Ambekar, professor of psychiatry at AIIMS Delhi, warned that excessive regulations might lead chemists to stop stocking essential medications due to perceived legal liability and low profit margins, potentially depriving genuine patients of necessary treatments.
Implementation and Future Outlook
The proposal is currently under review by the Drugs Consultative Committee (DCC), which has recommended forming a sub-committee to examine the matter in detail. The 67th DCC meeting held in November 2025 discussed the need to monitor the sale of certain drugs mentioned under both the Drugs Rules and the NDPS Act.
Implementation challenges are significant, particularly given India's fragmented pharmaceutical ecosystem with varying digital readiness across regions. Arpit Bhatia, director of Laborate Pharmaceuticals, emphasized that success depends on clear definitions, predictable processes, and a phased transition to ensure tighter controls don't unintentionally disrupt medicine access.
Legal experts have also highlighted the importance of balanced enforcement. Akash Karmakar, partner at Law Offices of Panag & Babu, noted that laws with wide discretionary penal powers should not be enforced arbitrarily or asymmetrically, as this could slow down supply chains for legitimate pain management and psychotropic drugs.
As India's pharmaceutical market continues to grow—projected to reach $130 billion by 2030 and $450 billion by 2047—the balance between effective regulation and maintaining access to essential medications remains a critical challenge for policymakers, industry stakeholders, and healthcare providers alike.
